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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 66-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-4478182-4/1/1 29-Jan-2013 66BAY99 3008740316 Rama Yogaswara Indonesia
 
112-4110784-1/1/1 29-Jan-2013 66BAY99 3008740316 Rama Yogaswara Indonesia
 
UPS-8918167-7/1/1 24-Jan-2013 66BBY44 3006355521 Service Point Eindhoven Netherlands
 
UPS-8918167-7/2/1 24-Jan-2013 66BBY44 3006355521 Service Point Eindhoven Netherlands
 
BMU-0021542-2/1/1 31-Jan-2013 66GBJ25 3009557982 Carepluss Pharma Sa De Cv Mexico
 
BMU-0021542-2/1/2 31-Jan-2013 66GBJ25 3009557982 Carepluss Pharma Sa De Cv Mexico
 
112-0659911-6/1/1 02-Jan-2013 66JCA01 1000549797 Merck Mexico, S.A. Mexico
 
M21-0747387-0/2/1 17-Jan-2013 66MCB36 3007195608 Ciron Drugs & Pharmaceuticals Pvt India
 
XXX-0214381-7/1/1 25-Jan-2013 66NCA06 3005029956 Torrent Pharmaceuticals Ltd. India
 
112-0814056-2/1/1/B 28-Jan-2013 66PBJ99 3007645944 Wizcoz Co., Ltd. Korea, Republic Of (South)
 
112-0814056-2/1/1/A 28-Jan-2013 66PBJ99 3007645944 Wizcoz Co., Ltd. Korea, Republic Of (South)
 
UPS-8915331-2/3/3 22-Jan-2013 66SCY36 3009914912 Jorge Alberto Caro Colombia
 
UPS-8706293-7/1/1 07-Jan-2013 66V99 3007225366 Herbal Technologies Bv Netherlands
 
XXX-0230620-8/1/12 07-Jan-2013 66VAY99 3008974514 Baxter Laboratories Colombia
 
XXX-0230620-8/1/13 07-Jan-2013 66VAY99 3008974514 Baxter Laboratories Colombia
 
XXX-0230620-8/1/14 07-Jan-2013 66VAY99 3008974514 Baxter Laboratories Colombia
 
DP4-0607624-1/1/1 11-Jan-2013 66VAY99 3004068085 Jerusalem Sesame Products Israel
 
UPS-8820770-5/2/1 02-Jan-2013 66VBJ99 3006608128 Newco Enterprise Inc. Canada
 
KM6-0060202-3/12/1 02-Jan-2013 66VBJ99 3009598223 Gate Foods Private Limited India
 
AEK-0731849-2/1/1 16-Jan-2013 66VBJ99 3003772990 Skycom Express Kuwait
 
960-0202665-4/6/1 18-Jan-2013 66VBJ99 3008699759 Omoleye Oguntoyinbo Nigeria
 
960-0202665-4/5/1 18-Jan-2013 66VBJ99 3008699759 Omoleye Oguntoyinbo Nigeria
 
D79-0018381-6/4/28 22-Jan-2013 66VBJ99 3006290992 D.R.V. S.A. Spain
 
D79-0018381-6/4/32 22-Jan-2013 66VBJ99 3006290992 D.R.V. S.A. Spain
 
D79-0018381-6/4/33 22-Jan-2013 66VBJ99 3006290992 D.R.V. S.A. Spain
 
KM6-0060267-6/29/1 25-Jan-2013 66VBJ99 3006064602 Emami Limited "Epip Complex India
 
KM6-0060764-2/19/1 30-Jan-2013 66VBJ99 3008614345 Procter & Gamble Hygiene and Health Care Ltd. India
 
KH5-0081414-1/8/1 25-Jan-2013 66VBL99 3008399937 Shenzhen Guanyujia Imports & Exports China
 
BOZ-0019111-0/2/1 28-Jan-2013 66VBL99 3006981196 Sviredenko Maria Russia
 
UPS-9101078-1/1/1 22-Jan-2013 66VBQ99 3002340645 Medex Scientific (Uk) Limited United Kingdom
 
KX2-0052804-3/3/1 29-Jan-2013 66VBR99 3006687088 Asmi International India
 
KX2-0052804-3/4/1 29-Jan-2013 66VBR99 3009765760 Ishwar Manufacturing Co. Pvt Ltd India
 
KX2-0052804-3/5/1 29-Jan-2013 66VBR99 3009765780 Progression Industires Pvt Ltd India
 
KX2-0052804-3/6/1 29-Jan-2013 66VBR99 3009765780 Progression Industires Pvt Ltd India
 
112-0090828-9/1/1 31-Jan-2013 66VBU99 3005157144 PT Galenium Pharmasia Laboratories Indonesia
 
XXX-0230620-8/1/6 07-Jan-2013 66VBY99 3005056587 Laboratorio San Jorge Ltd Colombia
 
HH7-0304453-2/10/2 08-Jan-2013 66VBY99 3008570131 Jamaica Teas Limited Jamaica
 
300-7170869-5/1/1/B 09-Jan-2013 66VBY99 2431229 SML Acquisition, LLC (aka San-mar Laboratories, Inc) United States
 
DO7-8284143-4/1/1/A 14-Jan-2013 66VBY99 3008725137 Para Pharmadirect France
 
DO7-8284143-4/1/1/B 14-Jan-2013 66VBY99 3008725137 Para Pharmadirect France
 
XXX-0230786-7/1/1 14-Jan-2013 66VBY99 3004641553 Merck, S.A. de C.V. Mexico
 
960-0202665-4/3/1 18-Jan-2013 66VBY99 3008699759 Omoleye Oguntoyinbo Nigeria
 
960-0202665-4/2/1 18-Jan-2013 66VBY99 3008699759 Omoleye Oguntoyinbo Nigeria
 
960-0202665-4/7/1 18-Jan-2013 66VBY99 3008699759 Omoleye Oguntoyinbo Nigeria
 
960-0202665-4/4/1 18-Jan-2013 66VBY99 3008699759 Omoleye Oguntoyinbo Nigeria
 
D52-6909307-1/1/3 22-Jan-2013 66VBY99 1000577653 Lanzhou Taibao Pharmaceutical Company, Ltd China
 
D52-6909307-1/1/6 22-Jan-2013 66VBY99 1000577653 Lanzhou Taibao Pharmaceutical Company, Ltd China
 
D52-6909307-1/1/9 22-Jan-2013 66VBY99 1000577653 Lanzhou Taibao Pharmaceutical Company, Ltd China
 
D52-6909307-1/1/15 22-Jan-2013 66VBY99 1000577653 Lanzhou Taibao Pharmaceutical Company, Ltd China
 
D52-6909307-1/1/36 22-Jan-2013 66VBY99 1000577653 Lanzhou Taibao Pharmaceutical Company, Ltd China
 
112-0092354-4/5/1 23-Jan-2013 66VBY99 3005742067 Al Harmoodi Computer Systems United Arab Emirates
 
EJG-0231531-1/1/1 23-Jan-2013 66VBY99 3004795940 Paloma Dead Sea, Ltd. Israel
 
AEK-0367500-2/1/1 25-Jan-2013 66VBY99 3009844222 Minh Chau Medicine Store Vietnam
 
BOZ-0019111-0/1/1 28-Jan-2013 66VBY99 3006981196 Sviredenko Maria Russia
 
XXX-0231532-4/1/1 28-Jan-2013 66VBY99 3007279393 Terumo Europe Bv Belgium
 
UPS-8915331-2/1/1 22-Jan-2013 66VCA99 3009914912 Jorge Alberto Caro Colombia
 
112-0660276-1/1/2 02-Jan-2013 66VCP99 3009468047 Rebeca Romo Lopez Mexico
 
112-0660276-1/1/3 02-Jan-2013 66VCP99 3009468047 Rebeca Romo Lopez Mexico
 
112-0660276-1/1/1 02-Jan-2013 66VCP99 3009468047 Rebeca Romo Lopez Mexico
 
112-9335625-4/1/1/A 23-Jan-2013 66VCY99 3006551843 Dermophisiologique Srl Italy
 
112-9335625-4/1/1/B 23-Jan-2013 66VCY99 3006551843 Dermophisiologique Srl Italy
 
112-9335625-4/1/1/C 23-Jan-2013 66VCY99 3006551843 Dermophisiologique Srl Italy
 
112-9335625-4/1/2/A 23-Jan-2013 66VCY99 3006551843 Dermophisiologique Srl Italy
 
112-9335625-4/1/2/B 23-Jan-2013 66VCY99 3006551843 Dermophisiologique Srl Italy
 
112-9335625-4/1/2/C 23-Jan-2013 66VCY99 3006551843 Dermophisiologique Srl Italy
 
KH5-0081414-1/27/1/B 25-Jan-2013 66VDA99 3009915363 Hong Kong Tianlong Organisms Technology International Group Hong Kong SAR
 
101-3212788-7/14/1 22-Jan-2013 66VDY99 3009553389 Dermalogica United States
 
101-3212788-7/15/1 22-Jan-2013 66VDY99 3009553389 Dermalogica United States
 
101-3212788-7/21/1 22-Jan-2013 66VDY99 3009553389 Dermalogica United States
 
101-3212788-7/48/1 22-Jan-2013 66VDY99 3009553389 Dermalogica United States
 
101-3212788-7/61/1 22-Jan-2013 66VDY99 3009553389 Dermalogica United States
 
101-3212788-7/64/1 22-Jan-2013 66VDY99 3009553389 Dermalogica United States
 
XXX-0227971-0/1/1 25-Jan-2013 66VDY99 3004465878 Merck Mexico
 
XXX-0227981-9/1/2 25-Jan-2013 66VDY99 3006812843 Laproff Colombia
 
XXX-0227981-9/1/3 25-Jan-2013 66VDY99 3008251123 Winthrop Pharmaceuticals Colombia
 
XXX-0231600-9/1/2 30-Jan-2013 66VDY99 3007558264 K-MAX HEALTH PRODUCTS CO United States
 
112-0221031-2/4/1 31-Jan-2013 66VIJ99 3009829940 The Stillman Company Inco United States
 
112-0221031-2/5/1 31-Jan-2013 66VIJ99 3009829939 Farway General Trading Llc United Arab Emirates
 
112-0221031-2/5/3 31-Jan-2013 66VIJ99 3008822013 U.B. Chemical Industries Co. Ltd Thailand
 
112-0221031-2/6/1 31-Jan-2013 66VIJ99 3003969573 L. P. Intercosmetic Co., Ltd. Thailand
 
112-0221031-2/7/1 31-Jan-2013 66VIJ99 3009829940 The Stillman Company Inco United States
 
XXX-0238130-0/1/2 09-Jan-2013 66YCQ99 3008882090 Glaxosmithkline New Zealand
 
336-7663697-4/1/1 07-Jan-2013 66YIK99 3005721395 Laboratorio Pablo Cassara Srl Argentina
 
BUP-1551223-2/2/1 07-Jan-2013 66YIY99 3003065803 Patheon Italia S.p.A. Italy
 
UPS-9184833-9/1/1/A 11-Jan-2013 66YPJ99 3009958078 Skinfix Inc Canada
 
UPS-9184833-9/1/1/B 11-Jan-2013 66YPJ99 3009958078 Skinfix Inc Canada
 
UPS-9184833-9/1/1/C 11-Jan-2013 66YPJ99 3009958078 Skinfix Inc Canada
 
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